Szeimies et al 2008

Title: A Clinical Study Comparing Methyl Aminolevulinate Photodynamic Therapy and Surgery in Small Superficial Basal Cell Carcinoma (8-20 mm) with a 12-Month Follow-up

Author: Szeimies RM, Ibbotson S, Murrell DF, Rubel D, Frambach Y, de Berker D, et al.

Journal Reference: J Eur Acad Dermatol Venereol. 2008;22(11):1302-11 (by clicking on this link you will be leaving this site - Galderma is not responsible for the content)

Key statements:

  • Methyl aminolevulinate photodynamic therapy (MAL-PDT) offers high efficacy, non-inferior to simple excision surgery, and a significantly better cosmetic outcome than surgery in the treatment of superficial basal cell carcinoma (sBCC).
  • Mean lesion count reduction at 3 months was 92.2% with MAL-PDT vs. 99.2% with surgery statistically confirming the non-inferiority hypothesis.
  • Cosmetic outcome was statistically superior for MAL-PDT at all time points and markedly improved with time, unlike surgery. At 12 months, 94.1% lesions treated with MAL-PDT had excellent or good cosmetic outcome vs. 59.8% with surgery (according to the investigator).
  • Adverse events (AEs) were more frequent with MAL-PDT vs. surgery but were of mild-to-moderate intensity and required less treatment than the surgery AEs.

Objectives: to compare the efficacy and cosmetic outcome of Metvix® with simple excision surgery for sBCC over a 1-year period. More specifically:

  • To show a non-inferior efficacy of Metvix® compared with surgery in terms of lesion response 3 months after the last treatment.
  • To show a superiority of Metvix® over surgery in terms of cosmetic outcome 12 months after the last treatment.

Design: a multicenter, controlled, randomized, open, parallel-group clinical trial performed in 27 international investigator centers (UK, Germany, Switzerland, Australia).

Patients were randomized to:

  • Metvix® - treated with one cycle of two treatment sessions 7 days apart. sBCC lesions showing non-clinical lesion response 3 months later could be retreated with a second cycle of two Metvix® sessions 7 days apart.
  • Surgery - one simple elliptical excision surgery was performed at baseline.

There was a 12-month follow-up period after last treatment procedure in both groups.

Evaluation/outcome measures:

  • Clinical lesion response at 3 months.
  • Lesion recurrence at 12 months.
  • Cosmetic outcome assessed by investigator and patient at 3, 6 and 12 months on a 4-point scale (poor, fair, good, excellent).
  • AEs.

Key Results: overall, 196 patients were enrolled with an average of 1.4 primary sBCC lesions per patient.

  • Clinical lesion response: mean lesion count reduction at 3 months was 92.2% with Metvix® vs. 99.2% with surgery. At 12 months, 9.3% recurred with Metvix® and none with surgery.
  • Cosmetic outcome was statistically superior for Metvix® at all time points. At 12 months, 94.1% of lesions treated with Metvix® had an excellent or good cosmetic outcome according to the investigator compared with 59.8% of lesions with surgery. This difference was confirmed with the patients' assessment. From a patient standpoint, 93% (Metvix®) vs. 51% (surgery) had a mean cosmetic outcome across lesions scored at least 'good' by the investigator. The proportion of excellent cosmetic outcome markedly improved with time with Metvix®, unlike surgery.
  • The incidence of treatment-related AEs was higher in the Metvix® group than in the surgery group (37% vs. 14.6%, respectively). All were of mild or moderate severity, except for one infection in the surgery group.

Other key points:

  • In the treatment of sBCC, this is the only published study comparing topical PDT with simple excision surgery, commonly regarded as the treatment of choice in this indication.
  • Metvix® is particularly suitable for the treatment of sBCC when the cosmetic outcome is important (young patients, risk of psychological impact) and for patients with extensive and multiple lesions.

Conclusion: Metvix® can be considered as a fully satisfying treatment option in small (<20 mm) sBCCs. Efficacy is not inferior and cosmetic outcome is significantly better as compared to the gold standard excision surgery.